Identifiers
- 510(k) Number
- K122020 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Photon Photon Plus is a dental diode laser device available in 3 Watt and 10 Watt configurations, operating at 810nm and 980nm wavelengths respectively. It is designed for soft tissue procedures and teeth whitening applications in dental practices.
The device is supplied by Zolar Technology & Mfg Co., Inc. and has received FDA 510(k) clearance with the product code GEX. It features multiple presets and customizable programs, with a compact and portable design suitable for various clinical workflows.
Frequently asked questions
What is the PHOTON PHOTON PLUS used for in dental practices?
The PHOTON PHOTON PLUS is designed for soft tissue procedures and teeth whitening applications in dental practices. It is available in 3 Watt and 10 Watt configurations operating at 810nm and 980nm wavelengths respectively.
How is the PHOTON PHOTON PLUS supplied and what are its key features?
The device is supplied by Zolar Technology & Mfg Co., Inc. and features multiple presets and customizable programs. It has a compact and portable design suitable for various clinical workflows.
What is the regulatory status of the PHOTON PHOTON PLUS?
The PHOTON PHOTON PLUS has received FDA 510(k) clearance with the product code GEX. It was determined to be substantially equivalent and received a traditional clearance type on June 5, 2013.
Are there different models of the PHOTON PHOTON PLUS available?
Yes, the PHOTON PHOTON PLUS is available in two configurations: a 3 Watt model operating at 810nm wavelength and a 10 Watt model operating at 980nm wavelength, both designed for different dental applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Diode Laser in Dentistry | Dental Laser Technology - Zolar, Photon Plus: Best Dental Diode Laser for Surgery & Whitening, Photon Series - Photon Plus Dental Diode Laser by Zolar ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122020 | Class II | Active |
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Manufacturer
- Manufacturer
- Zolar Technology & Mfg Co., Inc.
Sources (1)
- FDA 510(k) K122020 24 fields · synced Sep 26, 2026